Gastric bypass versus best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial

Ricardo V. Cohen, Tiago Veiga Pereira, Cristina Mamédio Aboud, Tarissa Beatrice Zanata Petry, José Luis Lopes Correa, Carlos Aurélio Schiavon, Carlos Eduardo Pompílio, Fernando Nogueira Quirino Pechy, Ana Carolina Calmon da Costa Silva, Lívia Porto Cunha da Silveira, Pedro Paulo de Paris Caravatto, Helio Halpern, Frederico de Lima Jacy Monteiro, Bruno da Costa Martins, Rogerio Kuga, Thais Mantovani Sarian Palumbo, Allon N. Friedman, Carel W. le Roux

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Abstract

Background: We compared the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) to best medical treatment in patients with diabetic kidney disease and obesity to determine which treatment is better. Methods: A 5 year, open-label, single-centre, randomised trial studied patients with diabetic kidney disease and class I obesity after 1:1 randomization to best medical treatment (n = 49) or RYGB (n = 51). The primary outcome was the proportion of patients achieving remission of microalbuminuria after 5 years. Secondary outcomes included improvements in diabetic kidney disease, glycemic control, quality of life, and safety. For efficacy outcomes, we performed an intention-to-treat (ITT) analysis. This study was registered with ClinicalTrials.gov, NCT01821508. Findings: 88% of patients (44 per arm) completed 5-year follow-up. Remission of albuminuria occurred in 59.6% (95% CI = 45.5–73.8) after best medical treatment and 69.7% (95% CI = 59.6–79.8) after RYGB (risk difference: 10%, 95% CI, −7 to 27, P = 0.25). Patients after RYGB were twice as likely to achieve an HbA1c ≤ 6.5% (60.2% versus 25.4%, risk difference, 34.9%; 95% CI = 15.8–53.9, P < 0.001). Quality of life after five years measured by the 36-Item Short Form Survey questionnaire (standardized to a 0-to-100 scale) was higher in the RYGB group than in the best medical treatment group for several domains. The mean differences were 13.5 (95% CI, 5.5–21.6, P = 0.001) for general health, 19.7 (95% CI, 9.1–30.3, P < 0.001) for pain, 6.1 (95% CI, −4.8 to 17.0, P = 0.27) for social functioning, 8.3 (95% CI, 0.23 to 16.3, P = 0.04) for emotional well-being, 12.2 (95% CI, 3.9–20.4, P = 0.004) for vitality, 16.8 (95% CI, −0.75 to 34.4, P = 0.06) for mental health, 21.8 (95% CI, 4.8–38.7, P = 0.01) for physical health and 11.1 (95% CI, 2.24–19.9, P = 0.01) for physical functioning. Serious adverse events were experienced in 7/46 (15.2%) after best medical treatment and 11/46 patients (24%) after RYGB (P = 0.80). Interpretation: Albuminuria remission was not statistically different between best medical treatment and RYGB after 5 years in participants with diabetic kidney disease and class 1 obesity, with 6–7 in ten patients achieving remission of microalbuminuria (uACR <30 mg/g) in both groups. RYGB was superior in improving glycemia, diastolic blood pressure, lipids, body weight, and quality of life. Funding: The study was supported by research grants from Johnson & Johnson Brasil, Oswaldo Cruz German Hospital, and by grant 12/YI/B2480 from Science Foundation Ireland (Dr le Roux) and grant 2015-02733 from the Swedish Medical Research Council (Dr le Roux). Dr Pereira was funded by the Chevening Scholarship Programme (Foreign and Commonwealth Office, UK).

Original languageEnglish
Article number101725
Pages (from-to)101725
Number of pages11
JournalEClinicalMedicine
Volume53
Early online date11 Nov 2022
DOIs
Publication statusPublished (in print/issue) - Nov 2022

Bibliographical note

Funding Information:
During the study, Dr Cohen reported receiving grants from Johnson & Johnson Medical Brasil. Dr Petry reported receiving grants from Johnson &Johnson Medical Brasil during the study. Dr Schiavon reported receiving grants from Ethicon and personal fees from Johnson & Johnson Brasil outside the submitted work. During the study, Dr Pompilio reported receiving grants from Johnson & Johnson Medical Brasil. Dr Sarian reported receiving grants from Johnson & Johnson Medical Brasil. Dr Nogueira Pechy reported receiving grants from Johnson & Johnson Medical Brasil and honoraria for lectures, Johnson&Johnson and Medtronic. Dr Porto da Silveira reported receiving grants from Johnson & Johnson Medical Brasil and honoraria for lectures, Johnson&Johnson and Medtronic. Dr Friedman reported partcipating on a Data.Safety Monitoring Board or Advisory Board for Gila Therapeutics and GI Dynamics, leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid for the International Society of Renal Nutrition and Metabolism and Editorial board- Journal of Renal Nutrition Dr le Roux reported receiving grants from Science Foundation Ireland, Health Research Board, European Federation for Study of Diabetes, and the Swedish Research Council during the conduct of the study and receiving an honorarium for lectures and scientific advisory board from Novo Nordisk, GI Dynamics, Sanofi, Johnson & Johnson Brasil, Keyron, Herbalife, and Boehringer Ingelheim outside the submitted work. Dr. Pereira reported receiving consulting fees from Novartis unrelated to the study. All other authors declare no competing interests.

Publisher Copyright:
© 2022 The Author(s)

Keywords

  • Bariatric surgery
  • Type 2 diabetes
  • Diabetic kidney disease
  • Obesity

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